175 Participants Needed

Ketogenic Diet Variations for Type 2 Diabetes and Obesity

(KETO-IM Trial)

PB
Overseen ByPaulina Blanco Cervantes, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Keto-CAN, Ketogenic Diet with Canola Oil, KETO-Can, Keto-SAT, Ketogenic Diet High in Saturated Fat, KETO-Sat, Traditional Ketogenic Diet, LFD, Low-Fat Diet for Type 2 Diabetes and Obesity?

Research suggests that ketogenic diets can be beneficial for weight loss and glucose control in people with diabetes, as seen in older patients where 54% achieved better glucose control and 79% lost weight. Additionally, a low-carbohydrate, ketogenic diet may improve blood sugar levels and reduce the need for diabetes medications.12345

Is the ketogenic diet generally safe for humans?

Based on available evidence, a well-formulated ketogenic diet does not appear to have major safety concerns for the general public and can be considered a first-line approach for obesity and diabetes. However, some adverse events like changes in cholesterol levels, constipation, and fatigue have been reported, so it's important to monitor health while on the diet.13567

How is the Keto-CAN and Keto-SAT treatment different from other treatments for type 2 diabetes and obesity?

The Keto-CAN and Keto-SAT treatments are unique because they are variations of the ketogenic diet, which is high in fat and low in carbohydrates, designed to induce ketosis (a state where the body burns fat for fuel). Keto-CAN uses canola oil, which is high in polyunsaturated fats, potentially offering better insulin sensitivity and lipid profiles compared to traditional saturated fat-rich ketogenic diets like Keto-SAT. This approach contrasts with low-fat diets, which have been less effective in managing obesity and diabetes.12568

What is the purpose of this trial?

The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are:* Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).* Effects on systemic inflammation and immune function.* Adherence to interventions.Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.Comparisons among groups at 3 and 6 months of intervention will be conducted.

Research Team

CC

Catherine Chan, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults with obesity or overweight and HbA1C levels at or above 5.7%, indicating high blood sugar, which can be a sign of prediabetes or diabetes. It's not suitable for individuals with certain cholesterol or triglyceride disorders, those undergoing menopause, on dialysis, transitioning transgender individuals, pregnant women, or anyone whose diet wouldn't allow them to follow the study's nutritional guidelines.

Inclusion Criteria

You are overweight or obese and have high HbA1C levels.

Exclusion Criteria

I have a family history of high cholesterol or high triglycerides.
I am on dialysis or advised to eat a low-protein diet due to kidney function.
Pregnant women
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three dietary treatments (KETO-Can, KETO-Sat, or LFD) and receive nutrition counseling for 6 months.

6 months
Monthly visits for dietary assessment and counseling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Keto-CAN
  • Keto-SAT
  • LFD
Trial Overview The study is testing three diets: a ketogenic diet supplemented with saturated fat (Keto-SAT), a ketogenic diet supplemented with canola oil (Keto-CAN), and a low-fat diet (LFD). Participants will be randomly assigned to one of these diets to see how they affect heart disease risk factors like cholesterol and blood sugar levels as well as inflammation and immune function over periods of 3 and 6 months.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: KETO-SatExperimental Treatment1 Intervention
KETO diet supplemented with butter and coconut oil (high in SFA).
Group II: KETO-CanExperimental Treatment1 Intervention
KETO diet supplemented with Canola oil (high in MUFA and omega-3 FA).
Group III: Low fat diet (LFD)Active Control1 Intervention
Low fat diet supplemented with whole grain foods (pasta or brown rice) and oatmeal.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Findings from Research

In a study involving 11 healthy, normal-weight participants, a high-fat ketogenic diet (KD) did not improve cognitive function, mood, or sleep quality compared to a high-carbohydrate, low-fat diet over a 3-week period.
Despite achieving nutritional ketosis, the KD showed no significant effects on tasks measuring vigilance, memory, or executive function, indicating that this diet may not enhance cognitive performance in healthy individuals.
Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial.Iacovides, S., Goble, D., Paterson, B., et al.[2023]
Long-term consumption of a ketogenic diet in rats led to significant weight loss, decreased blood sugar levels, and increased blood ketones, indicating effective metabolic changes associated with this diet.
However, the ketogenic diet also resulted in metabolic acidosis and anemia, as evidenced by lower blood pH and reduced levels of erythrocytes, hemoglobin, and hematocrit, alongside a decrease in antioxidant enzyme superoxide dismutase levels.
Long-Term Ketogenic Diet Induces Metabolic Acidosis, Anemia, and Oxidative Stress in Healthy Wistar Rats.Arsyad, A., Idris, I., Rasyid, AA., et al.[2022]
In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.
While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.
Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients.Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

References

Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial. [2023]
Long-Term Ketogenic Diet Induces Metabolic Acidosis, Anemia, and Oxidative Stress in Healthy Wistar Rats. [2022]
Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. [2023]
A low-carbohydrate, ketogenic diet to treat type 2 diabetes. [2020]
Differential metabolic effects of saturated versus polyunsaturated fats in ketogenic diets. [2022]
The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. [2023]
The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. [2022]
Ketogenic diet in endocrine disorders: Current perspectives. [2019]
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